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FDA 510(k)

COBAS INTEGRA HDL-CHOLESTEROL DIRECT

K-Number: K973284 · 1997-12-18

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1997-12-18
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA HDL-CHOLESTEROL DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K973284. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA HDL-CHOLESTEROL DIRECT?

COBAS INTEGRA HDL-CHOLESTEROL DIRECT is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K973284.

When did COBAS INTEGRA HDL-CHOLESTEROL DIRECT receive FDA 510(k) clearance?

COBAS INTEGRA HDL-CHOLESTEROL DIRECT received FDA 510(k) clearance on 1997-12-18, under 510(k) number K973284.

Who is the listed applicant for COBAS INTEGRA HDL-CHOLESTEROL DIRECT?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS INTEGRA HDL-CHOLESTEROL DIRECT?

The FDA product code for COBAS INTEGRA HDL-CHOLESTEROL DIRECT is CHH.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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Related Devices (Code: CHH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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